Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®

Phase 1

• Conditions: Breast Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002039-28-ES
• Lead Sponsor: Sandoz GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Study Completion: 2013-12-04
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

1.Written informed consent before any assessment is performed
2.Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy
3.Women ? 18 years of age
4.Estimated life expectancy of more than six months
5.Eastern cooperative oncology group (ECOG) performance status ? 2
6.Adequate bone marrow function on Cycle 1 Day 1 prior to chemotherapy administration:
?ANC ? 1.5 x 109/L
?Platelet count ? 100 x 109/L
?Hemoglobin ? 10 g/dL
7.Total bilirubin not higher than the upper limit of normal (ULN), unless the patient has Gilbert`s syndrome
8.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level ? 2 x ULN
9.Liver-derived alkaline phosphatase level ? 3 x ULN
10.Creatinine ? 1.5 x ULN
11.For all women of childbearing potential: negative serum pregnancy test within seven days prior to randomization, and using a highly effective method of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 297
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.History of chronic myeloid leukemia or myelodysplastic syndrome
2.History or presence of sickle cell disease
3.Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
4.Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation or chemotherapy and their evaluation such as.:
?Active uncontrolled infection
?Clinically significant impairment of left ventricular ejection fraction (LVEF) (measured within three month before study entry by echocardiography or multiple-gated acquisition scan (MUGA) must be above the lower limit of normal for the respective center)
?Severe valvular heart disease, myocardial infarction, unstable angina pectoris, uncontrolled hypertension or uncontrolled arrhythmias within six months from study entry
?Significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
5.Concurrent or prior radiotherapy within four weeks of randomization
6.Concurrent or prior chemotherapy for breast cancer
7.Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
8.Concurrent prophylactic antibiotics
9.Prior bone marrow or stem cell transplant
10.Previous therapy with any recombinant human granulocyte-colony stimulating factor (rhG-CSF) product
11.Known hypersensitivity to Escherichia coli (E. coli) proteins or any of the excipients used in the investigational medicinal products (IMPs)
12.Patient known to have HIV, Hepatitis B, Hepatitis C infection or who have positive serology for HIV, Hepatitis B or Hepatitis C at screening
13.Known control drug addiction, including alcoholism
14.Participation in any other clinical study using an IMP or device within three months before the screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To further compare LA EP2006 and Neulasta® with respect to the efficacy, safety, and immunogenicity of both products.;Primary end point(s): ?Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC < 0.5 × 109/L during Cycle 1 of chemotherapy;Timepoint(s) of evaluation of this end point: ?Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC < 0.5 × 109/L during Cycle 1 of chemotherapy;Main Objective: To assess the efficacy of LA EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN), defined as number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 109/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel] in combination with Adriamycin® [doxorubicin] and Cytoxan® [cyclophosphamide]) in breast cancer patients.